Hybrid Effectiveness-implementation Research Articles

Successful Implementation of the AIUM Standardized 4-Year Residency Ultrasound Curriculum in Obstetrics and Gynecology: Lessons Learned and Way Forward.

Significant disparities in sonographic education exist in Obstetrics and Gynecology programs in the United States. To address the lack of standardization in ultrasound teaching, the American Institute of Ultrasound in Medicine (AIUM) assembled a multi-society task force in 2018 that resulted in the publication of a Consensus Report outlining a standardized ultrasound curriculum and competency assessment. The primary objective of the study was to implement the AUIM standardized curriculum within an Obstetrics and Gynecology residency program at a tertiary medical center, and report on the early implementation experience. The secondary objective was to assess current national practices in ultrasound training in Obstetrics and Gynecology residency programs. Study design was an effectiveness-implementation hybrid study of a structured ultrasound educational program based on the 2018 AIUM Consensus Report. The theoretical portion of the curriculum consisted of 26 hours of didactic lectures distributed over 4 years. For the practical component, residents received instruction from faculty and sonographers and independently acquired the required images as part of their regular clinical work. Simulator app access was also provided for additional opportunities to practice and acquire images. Deidentified images for the required competencies were uploaded to a WhatsApp group for review. Theoretical knowledge was assessed with a series of multiple-choice exams. Practical skills were assessed through grading of images submitted through WhatsApp as well as direct observations of resident scans. At the completion of 4 years, the assessment of both theoretical knowledge and practical skills was carried out using the ISUOG Basic Training Examination. National patterns in the area of ultrasound education were assessed with a four-question electronic survey of Obstetrics and Gynecology program directors in the United States. Analysis of both portions of the study was primarily descriptive. Four Obstetrics and Gynecology residents completed the curriculum spanning postgraduate years 1 through 4. The number of competencies completed ranged from 7 to 19 out of 41. All of the residents passed the theoretical and practical components of the ISUOG Basic Training Examination. For the residency program director survey portion of the study, response rate was 20% (59 of 290). Among the respondents, 55.9% reported having a structured curriculum and 34.4% reported implementing the AIUM curriculum. The two most commonly cited obstacles to implementation of structured ultrasound teaching were uncertainty with how to start the process (49.2%) and lack of faculty engagement (49.2%). Implementation of the AIUM Curriculum within the framework of an Obstetrics and Gynecology residency program at a tertiary medical center is feasible. In our experimental group, completion of the curriculum resulted in passing of an internationally recognized validated assessment. Obstacles to implementation in our program included a wide range of engagement and participation among residents, and limited opportunities to obtain some of the required competencies. Identification of obstacles to implementation from the perspective of residency program directors is critical for developing targeted approaches to ensure widespread implementation. Successful standardized validated sonographic training of graduating Obstetrics and Gynecology residents is crucial for this operator-dependent modality that has tremendous implications on patient safety and clinical care.

Promotion of a social prescribing pathway to general practitioners in a rural area (a feasibility study protocol)

PurposePsychosocial problems, including social isolation and loneliness, are prevalent in rural communities and can impact the use of health services and health outcomes. Current approaches to managing patients with predominantly psychosocial issues may not be the most appropriate. Social prescribing (SP) is a relatively new way of linking patients with sources of non-medical support within the community. Emerging literature suggests that community-based, non-medical activities are an effective and preferred approach to managing psychosocial problems. However, there is little evidence describing the attitudes of general practitioners (GPs) towards formal SP pathways.Design/methodology/approachThis research will occur in a general practice in a rural area of Tasmania, Australia. The project will deliver an education module to rural GPs to highlight the benefits of SP and provide a streamlined pathway for referring patients to community support hubs. Existing community organisations will act as “link workers” to connect patients with suitable community activities. GPs will complete a baseline and follow-up survey to measure their perception of SP and the acceptability, feasibility and appropriateness of such an intervention.FindingsThe acceptability, feasibility and appropriateness of the pathway will be assessed using published measures. Free-text responses to open-ended questions will be used to complement the quantitative data. A hybrid effectiveness-implementation method will be used to gather information about the rate of uptake and quality of the SP referral process and identify barriers and facilitators of the process in a real-world setting.Research limitations/implicationsWhile qualitative data for SP programmes is predominantly positive, quantitative data is lacking. Although the planned project is relatively short, it will provide a basis for future SP programme implementation and guide the approach to data collection and implementation assessment.Social implicationsThe barriers to and facilitators of introducing a SP programme in a rural general practice setting may be used to guide the development and implementation of future large-scale SP interventions. This research is both timely and relevant as the problem of social isolation and loneliness, especially in rural areas of Australia, is becoming more well-recognised as a driver of poor health and unnecessary health service usage.Originality/valueUsing SP to address psychosocial risks may reduce healthcare burden and costs. Few SP programmes have been delivered and formally assessed in Australia, and the best way to implement SP locally remains unclear. By delivering a SP intervention in a rural setting and assessing GPs’ responses, future SP projects will be better able to design and integrate social and medical care services.

Validating cognitive screening in young people with first-episode psychosis: The CogScreen protocol.

Cognitive impairments are a core feature of first-episode psychosis (FEP) and one of the strongest predictors of long-term psychosocial functioning. Cognition should be assessed and treated as part of routine clinical care for FEP. Cognitive screening offers the opportunity to rapidly identify and triage those in most need of cognitive support. However, there are currently no validated screening measures for young people with FEP. CogScreen is a hybrid effectiveness-implementation study which aims to evaluate the classification accuracy (relative to a neuropsychological assessment as a reference standard), test-retest reliability and acceptability of two cognitive screening tools in young people with FEP. Participants will be 350 young people (aged 12-25) attending primary and specialist FEP treatment centres in three large metropolitan cities (Adelaide, Sydney, and Melbourne) in Australia. All participants will complete a cross-sectional assessment over two sessions including two cognitive screening tools (Screen for Cognitive Impairment in Psychiatry and Montreal Cognitive Assessment), a comprehensive neuropsychological assessment battery, psychiatric and neurodevelopmental assessments, and other supplementary clinical measures. To determine the test-retest reliability of the cognitive screening tools, a subset of 120 participants will repeat the screening measures two weeks later. The protocol, rationale, and hypotheses for CogScreen are presented. CogScreen will provide empirical evidence for the validity and reliability of two cognitive screening tools when compared to a comprehensive neuropsychological assessment. The screening measures may later be incorporated into clinical practice to assist with rapid identification and treatment of cognitive deficits commonly experienced by young people with FEP.

The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial

Background Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs.MethodsThe study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation.DiscussionOptimizing cardiac rehabilitation centres’ delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI.Trial registrationClinicalTrials.gov. Identifier: NCT05889416. Registered 2023-03-23.

Adapting the World Health Organization’s Surgical Safety Checklist to High-Income Settings: A Hybrid Effectiveness-Implementation Trial Protocol

Adapting the World Health Organization’s Surgical Safety Checklist to High-Income Settings: A Hybrid Effectiveness-Implementation Trial Protocol

Editorial: Hybrid effectiveness-implementation trial designs—critical assessments, innovative applications, and proposed advancements

Editorial: Hybrid effectiveness-implementation trial designs—critical assessments, innovative applications, and proposed advancements

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial

BackgroundAlthough the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system.MethodsWe randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses.ConclusionThe study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.Trial registrationClinical trials NCT05817396. Registered on April 18, 2023.

Prevention of dementia using mobile phone applications (PRODEMOS): a multinational, randomised, controlled effectiveness-implementation trial.

The expected increase of dementia prevalence in the coming decades will mainly be in low-income and middle-income countries and in people with low socioeconomic status in high-income countries. This study aims to reduce dementia risk factors in underserved populations at high-risk using a coach-supported mobile health (mHealth) intervention. This open-label, blinded endpoint, hybrid effectiveness-implementation randomised controlled trial (RCT) investigated whether a coach-supported mHealth intervention can reduce dementia risk in people aged 55-75 years of low socioeconomic status in the UK or from the general population in China with at least two dementia risk factors. The primary effectiveness outcome was change in cardiovascular risk factors, ageing, and incidence of dementia (CAIDE) risk score from baseline to after 12-18 months of intervention. Implementation outcomes were coverage, adoption, sustainability, appropriateness, acceptability, fidelity, feasibility, and costs assessed using a mixed-methods approach. All participants with complete data on the primary outcome, without imputation of missing outcomes were included in the analysis (intention-to-treat principle). This trial is registered with ISRCTN, ISRCTN15986016, and is completed. Between Jan 15, 2021, and April 18, 2023, 1488 people (601 male and 887 female) were randomly assigned (734 to intervention and 754 to control), with 1229 (83%) of 1488 available for analysis of the primary effectiveness outcome. After a mean follow-up of 16 months (SD 2·5), the mean CAIDE score improved 0·16 points in the intervention group versus 0·01 in the control group (mean difference -0·16, 95% CI -0·29 to -0·03). 1533 (10%) invited individuals responded; of the intervention participants, 593 (81%) of 734 adopted the intervention and 367 (50%) of 734 continued active participation throughout the study. Perceived appropriateness (85%), acceptability (81%), and fidelity (79%) were good, with fair overall feasibility (53% of intervention participants and 58% of coaches), at low cost. No differences in adverse events between study arms were found. A coach-supported mHealth intervention is modestly effective in reducing dementia risk factors in those with low socioeconomic status in the UK and any socioeconomic status in China. Implementation is challenging in these populations, but those reached actively participated. Whether this intervention will result in less cognitive decline and dementia requires a larger RCT with long follow-up. EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China. For the Mandarin translation of the abstract see Supplementary Materials section.

Implementation of an electronic health record system during global surgical outreach: A prospective evaluation of success and sustainability.

The burden of musculoskeletal conditions continues to grow in low- and middle-income countries. Among thousands of surgical outreach trips each year, few organizations electronically track patient data to inform real-time care decisions and assess trip impact. We report the implementation of an electronic health record (EHR) system utilized at point of care during an orthopedic surgical outreach trip. In March 2023, we implemented an EHR on an orthopedic outreach trip to guide real-time care decisions. We utilized an effectiveness-implementation hybrid type 3 design to evaluate implementation success. Success was measured using outcomes adopted by the World Health Organization, including acceptability, appropriateness, feasibility, adoption, fidelity, and sustainability. Clinical outcome measures included adherence to essential quality measures and follow-up numerical rating system (NRS) pain scores. During the 5-day outreach trip, 76 patients were evaluated, 25 of which underwent surgery beforehand. The EHR implementation was successful as defined by: mean questionnaire ratings of acceptability (4.26), appropriateness (4.12), feasibility (4.19), and adoption (4.33) at least 4.00, WHO behaviorally anchored rating scale ratings of fidelity (6.8) at least 5.00, and sustainability (80%) at least 60% follow-up at 6months. All clinical quality measures were reported in greater than 80% of cases with all measures reported in 92% of cases. NRS pain scores improved by an average of 2.4 points. We demonstrate successful implementation of an EHR for real-time clinical use on a surgical outreach trip. Benefits of EHR utilization on surgical outreach trips may include improved documentation, minimization of medical errors, and ultimately improved quality of care.

Effect of Financial Penalties on Appointment Nonadherence in Academic Obstetrics and Gynecology Clinics [ID 2683433

INTRODUCTION: The objective of this study was to examine the effect of patient financial penalties on appointment nonadherence within a single academic institution's obstetrics and gynecology outpatient clinics. METHODS: This retrospective policy effectiveness-implementation hybrid study included administrative data from all appointments at a single academic institution’s obstetrics and gynecology outpatient clinics from May 1, 2018, to April 30, 2022. Institutional review board approval was waived for this study. The department-wide patient financial penalty policy for appointment nonadherence was implemented on May 1, 2020. We conducted an interrupted time series analysis after stratifying by insurance (Medicaid versus all insurance). Poisson regression was used to calculate incidence risk ratios (IRRs) with 95% CIs. RESULTS: There were 414,006 obstetrics and gynecology outpatient clinic appointments (pre-implementation [pre]: 208,696; post-implementation [post]: 205,410). Of these, 58,473 (14.1%; pre: 29,533 [14.2%]; post: 28,940 [14.1%]) appointments were not attended. Compared to the all insurance group, Medicaid patients had a higher rate of appointment nonadherence (36,872/188,343 [19.6%]; pre: 18,070 [19.6%]; post: 18,802 [19.6%]). In the all insurance group, the implementation of financial penalties resulted in a 4% increase in nonadherence (IRR 1.04 [95% CI, 0.99–1.09]). In the Medicaid group, the implementation of financial penalties did not change nonadherence (IRR 1.00 [95% CI, 0.98–1.02]). There was no significant difference in the coefficient between Medicaid and all insurance groups (P>.05). CONCLUSION: Institutional implementation of patient financial penalties for appointment nonadherence did not change appointment nonadherence rates in obstetrics and gynecology outpatient clinics. The lack of change persisted after stratifying by insurance despite the inability to charge Medicaid patients a financial penalty for appointment nonadherence.

Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention

ObjectiveTo compare the clinical and cost effectiveness of the Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT), a community-based, stratified, multidisciplinary intervention consisting of exercise, education, psychological and nutrition delivered through a chronic care model to usual hospital care in adults with knee osteoarthritis (OA). MethodsPragmatic, parallel-arm, single-blinded superiority RCT trial. Community-dwelling, ambulant adults with knee OA (Kellgren-Lawrence grade > 1; Knee Injury and OA Outcome Score (KOOS4) ≤ 75) were enrolled. Primary outcome was KOOS4 at 12-months; secondary outcomes included: quality of life, physical performance measures, symptom satisfaction, psychological outcomes, dietary habits, and global perceived effect. Intention-to-treat analysis using generalized linear model (GLM) and regression modelling were conducted. Economic evaluation through a societal approach was embedded. Results110 participants (55 control, 55 intervention) were randomized. No between-group difference found for the primary outcome (MD [95%CI]: -1.86 [-9.11. 5.38]), although both groups demonstrated within-group improvement over 12-months. Among the secondary outcomes, the CONNACT group demonstrated superior dietary change (12 months) and physical performance measures (3 months), and global perceived effect (6 months). While there was no between-group difference in total cost, significant productivity gains (reduced indirect cost) were seen in the CONNACT group. ConclusionCONNACT was not superior to usual care at 1 year. Further efforts are needed to understand the underlying contextual and implementation factors in order to further improve and refine such community-based, stratified care models moving forward. Trial RegistrationClinicaltrials.gov Identifier: NCT03809975. Registered January 18 2019. https://clinicaltrials.gov/ct2/show/NCT03809975

Implementing a Treatment for People with Serious Mental Illness in Jail: A Mixed-Methods Study of Stakeholder Perspectives on Feasibility and Acceptability.

People with mental illness are over-represented in the U.S. criminal legal system. Jail presents an optimal opportunity to provide needed mental health care as the entry point to corrections. However, there is a lack of programming available in jails, which may be partly due to limited understanding of how to successfully implement interventions in this complex setting. We implemented a nine-session psychotherapeutic intervention for people with serious mental illness in a county jail. As part of a larger implementation-effectiveness hybrid study, we gathered mixed-methods data from stakeholders (treatment recipients and jail administrators) on the feasibility and acceptability of the intervention's implementation. In focus group discussions and qualitative interviews, treatment recipients (n = 29) provided qualitative and quantitative data on their perceptions of the implementation's feasibility and acceptability. Jail administrators (n = 6) completed two quantitative self-report measures on their perceptions of the treatment's feasibility and acceptability. Qualitative analyses were conducted by two coders using inductive thematic template analysis; seven global themes relating to treatment recipients' perceptions of the assets and hindrances to feasibility and acceptability were developed and are presented with supporting quotations. Quantitatively, all treatment recipients endorsed the intervention's feasibility (100%), and nearly all (97%) endorsed its acceptability. On both self-report measures, jail administrators' mean scores fell above a-priori thresholds indicating feasibility and acceptability. We found qualitative and quantitative support for the use of this intervention in jail from both sets of stakeholders. These results have implications for clinical service and policy in jail, where service providers struggle to meet the considerable demand for mental health services.

Barriers to dental utilization among Medicaid-enrolled young children from primary care practices in Northeast Ohio.

To evaluate the individual and community factors that contribute to dental utilization among young children on Medicaid utilizing the Anderson Model and the Socio-Ecological Framework. This observational cross-sectional study was conducted using baseline data (socio-demographics, clinical dental need) from a cluster-randomized hybrid effectiveness-implementation trial among 1021 child-parent dyads recruited from primary care practices across northeast Ohio. The baseline data were then linked to dental Medicaid claims data (categorized as any dental visit, volume, and type in the past 12 months) and ICD-10 codes from the child's EHR data (individual-level) together with Dental Health Provider Shortage Area (HPSA) status and Area Deprivation Index (ADI) which were obtained at the neighbourhood-level using home address of each dyad (community-level). Multivariable analyses using generalized estimating equations (GEE) accounted for clustering by practice, and models included individual-level alone, and individual + community-level factors to evaluate their effects on dental utilization. Medicaid claims data indicated that among the 1021 children (mean age: 4.3 ± 1.1 years; 54.4% males; 43.8% Black, Non-Hispanic), a majority of children were seeing the dentist at least once a year by the age of 4 (56.1%). The mean ADI of their neighbourhoods was 109.22 (20.2) and 27.5% lived in a HPSA area. The GEE analyses revealed that individual factors such as older children, parents being married, and continuous Medicaid enrollment were associated with significantly higher dental utilization. Among community factors, being in a HPSA had an OR = 1.53 (CI: 1.03, 2.27) associated with higher dental utilization. Being in a HPSA was associated with higher dental utilization possibly due to dentists or safety net dental clinics in these areas accepting Medicaid-eligible children.

Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial

BackgroundDepression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, including human support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. ObjectiveThe current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. MethodsThe proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 110 patient participants, with a loss-to-follow-up rate of 30 %. DiscussionA study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services. RegistrationClinicalTrials.gov; NCT06230237.

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials

Clinical Remote Monitoring of Individuals With Spinal Cord Injury at Risk for Pressure Injury Recurrence Using mHealth: Protocol for a Pilot, Pragmatic, Hybrid Implementation Trial.

Pressure injuries are one of the most challenging secondary conditions for individuals with spinal cord injuries and related disorders (SCI/D) owing to inherent, lifelong risk factors that include a lack of sensory and motor function below the level of injury and reliance on a wheelchair for daily mobility, resulting in prolonged periods of sitting. Although many factors contribute to the development of pressure injuries, the pressure between the skin and a surface is always a factor and the development of injury is dependent on the magnitude and duration of the pressure. Clinically, broad recommendations for relieving pressure are used because we know very little about the unique day-to-day life patterns of the individual wheelchair user. Typically, it is after the occurrence of a pressure injury that the therapist will check equipment fit and the effectiveness of pressure offloading and ask about other surfaces they sit on in their home and community. This time-lapsed, largely self-reported data are fraught with recall bias and inaccuracies that the therapist incorporates into a plan of care. This study's objective is to pilot-test the implementation and clinical effectiveness of a telehealth model of care combined with our mobile health (mHealth) Assisted Weight-Shift device for remote monitoring of factors related to maintaining skin health and wheelchair setup. Our overall hypothesis is that this study will result in an effective implementation plan, and the enhanced connected model of care using remote monitoring of pressure management will result in pilot-level, improved clinical outcomes for adults with spinal cord injury at high risk for pressure injury recurrence. For all aims, we will use a mixed methods design using an exploratory, sequential approach to include the strengths of both qualitative and quantitative data. For aims 1 and 2, we will iteratively collect qualitative data from therapists, patients with SCI/D, and other stakeholders. For aim 3, we will perform a hybrid effectiveness-implementation randomized controlled trial to pilot-test the intervention. The projected results include an iteratively developed and tested implementation plan that meets moderate to high levels of acceptability, feasibility, and appropriateness. Additionally, the pilot trial results are expected to show positive trends in relevant clinical outcomes related to reduced pressure injury incidence, recurrence, and improved healing when compared with the standard of care. Currently, 6 participants have been recruited for our aim-1 qualitative study. This study will expand upon our previous study to move the Assisted Weight-Shift system into routine clinical care, which was a strong desire of adults with SCI/D for improved individualized care plans to prevent pressure injuries. The results of this study will guide the next steps in a full, hybrid effectiveness-implementation trial with the goal of improving care to prevent pressure injuries. DERR1-10.2196/51849.

Family cascade screening for equitable identification of familial hypercholesterolemia: study protocol for a hybrid effectiveness-implementation type III randomized controlled trial

BackgroundFamilial hypercholesterolemia (FH) is a heritable disorder affecting 1.3 million individuals in the USA. Eighty percent of people with FH are undiagnosed, particularly minoritized populations including Black or African American people, Asian or Asian American people, and women across racial groups. Family cascade screening is an evidence-based practice that can increase diagnosis and improve health outcomes but is rarely implemented in routine practice, representing an important care gap. In pilot work, we leveraged best practices from behavioral economics and implementation science—including mixed-methods contextual inquiry with clinicians, patients, and health system constituents—to co-design two patient-facing implementation strategies to address this care gap: (a) an automated health system-mediated strategy and (b) a nonprofit foundation-mediated strategy with contact from a foundation-employed care navigator. This trial will test the comparative effectiveness of these strategies on completion of cascade screening for relatives of individuals with FH, centering equitable reach.MethodsWe will conduct a hybrid effectiveness-implementation type III randomized controlled trial testing the comparative effectiveness of two strategies for implementing cascade screening with 220 individuals with FH (i.e., probands) per arm identified from a large northeastern health system. The primary implementation outcome is reach, or the proportion of probands with at least one first-degree biological relative (parent, sibling, child) in the USA who is screened for FH through the study. Our secondary implementation outcomes include the number of relatives screened and the number of relatives meeting the American Heart Association criteria for FH. Our secondary clinical effectiveness outcome is post-trial proband cholesterol level. We will also use mixed methods to identify implementation strategy mechanisms for implementation strategy effectiveness while centering equity.DiscussionWe will test two patient-facing implementation strategies harnessing insights from behavioral economics that were developed collaboratively with constituents. This trial will improve our understanding of how to implement evidence-based cascade screening for FH, which implementation strategies work, for whom, and why. Learnings from this trial can be used to equitably scale cascade screening programs for FH nationally and inform cascade screening implementation efforts for other genetic disorders.Trial registrationClinicalTrials.gov, NCT05750667. Registered 15 February 2023—retrospectively registered, https://clinicaltrials.gov/study/NCT05750667.

Implementation of an internet-based stress management program in micro- and small-sized enterprises: a study protocol for a pre-post feasibility study of the effectiveness-implementation hybrid type 2 trial

BackgroundAlthough internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation.ObjectivesThis paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs (“WellBe-LINE”) in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials.MethodsFor this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees’ gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees’ burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews.DiscussionThis pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data.ConclusionsThis feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs.Trial registrationUMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022.https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570

Impact of Local Tailoring on Acute Stroke Care in 21 Disparate Emergency Departments: A Prospective Stepped Wedge Type III Hybrid Effectiveness-Implementation Study.

Faster delivery of tPA (tissue-type plasminogen activator) results in better health outcomes for eligible patients with stroke. Standardization of stroke protocols in emergency departments (EDs) has been difficult, especially in nonstroke centers. We measured the effectiveness of a centrally led implementation strategy with local site tailoring to sustain adherence to an acute stroke protocol to improve door-to-needle (DTN) times across disparate EDs in a multihospital health system. Prospective, type III hybrid effectiveness-implementation cohort study measuring performance at 21 EDs in Utah and Idaho (stroke centers [4]/nonstroke centers [17]) from January 2018 to February 2020 using a nonrandomized stepped-wedge design, monthly repeated site measures and multilevel hierarchical modeling. Each site received the implementation strategies in 1 of 6 steps providing control and intervention data. Co-primary outcomes were percentage of DTN times ≤60 minutes and median DTN time. Secondary outcomes included percentage of door-to-activation of neurological consult times ≤10 minutes and clinical effectiveness outcomes. Results were stratified between stroke and nonstroke centers. A total of 855 474 ED patient encounters occurred with 5325 code stroke activations (median age, 69 [IQR, 56-79] years; 51.8% female patients]. Percentage of door-to-activation times ≤10 minutes increased from 47.5% to 59.9% (adjusted odds ratio, 1.93 [95% CI, 1.40-2.67]). A total of 615 patients received tPA of ≤3 hours from symptom onset (median age, 71 [IQR, 58-80] years; 49.6% female patients). The percentage of DTN times ≤60 minutes increased from 72.5% to 86.1% (adjusted odds ratio, 3.38, [95% CI, 1.47-7.78]; stroke centers (77.4%-90.0%); nonstroke centers [59.3%-72.1%]). Median DTN time declined from 46 to 38 minutes (adjusted median difference, -9.68 [95% CI, -17.17 to -2.20]; stroke centers [41-35 minutes]; nonstroke centers [55-52 minutes]). No differences were observed in clinical effectiveness outcomes. A centrally led implementation strategy with local site tailoring led to faster delivery of tPA across disparate EDs in a multihospital system with no change in clinical effectiveness outcomes including rates of complication. Disparities in performance persisted between stroke and nonstroke centers.

Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial.

Knee osteoarthritis (KOA) is one of most prevalent and fastest-growing causes of pain, impaired mobility, and poor quality of life in the rapidly aging population worldwide. There is a lack of high-quality evidence on the efficacy of traditional Chinese medicine (TCM), particularly acupuncture, and a lack of KOA practice guidelines that are tailored to unique population demographics and tropical climates. Our HARMOKnee (Heat and Acupuncture to Manage Osteoarthritis of the Knee) trial aims to address these gaps by evaluating the short- and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for patients with KOA to facilitate the large-scale implementation of a comprehensive and holistic model of care that harmonizes elements of Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. A multicenter, pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomized controlled trial will be conducted. We intend to recruit 100 patients with KOA randomized to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). The inclusion criteria are being a community ambulator and having primary KOA, excluding patients with secondary arthritis or previous knee replacements. The primary outcome measure is the Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction, and global outcome measures at 6, 12, and 26 weeks. A mixed method approach through an embedded process evaluation will facilitate large-scale implementation. An economic evaluation will be performed to assess financial sustainability. Patient enrollment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analyzed and publicized as they are obtained. As of November 6, 2023, our patient enrollment stands at 65 individuals. The findings of our HARMOKnee study will contribute substantial evidence to the current body of literature regarding the effectiveness of acupuncture treatment for KOA. Additionally, we aim to facilitate the creation of standardized national guidelines for evidence-based practice that are specifically tailored to our unique population demographics. Furthermore, we seek to promote the adoption and integration of acupuncture and heat therapy into existing treatment models. ClinicalTrials.gov NCT05507619; https://clinicaltrials.gov/study/NCT05507619. DERR1-10.2196/54352.